Evidence map›Paper›PMID 41494018›Full record

ArticlePloS one2026

Adverse events associated with cyclophosphamide: A pharmacovigilance study using the FDA adverse event reporting system.

Hui Zhang, Minghao Lin, Dexi Zhao, Yujuan Fu

Abstract read
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Hui ZhangChangchun University of Chinese Medicine, Changchun, China.
Minghao LinChangchun University of Chinese Medicine, Changchun, China.
Dexi ZhaoChangchun University of Chinese Medicine, Changchun, China.
Yujuan FuChangchun University of Chinese Medicine, Changchun, China.ORCID https://orcid.org/0009-0001-9485-1839

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCyclophosphamide(CHOP) is a widely used chemotherapeutic agent belonging to the class of alkylating agents. It primarily inhibits the proliferation of tumor cells by interfering with DNA replication and transcription. CHOP has been approved for the treatment of various types of malignant tumors. The aim of this research is to assess adverse events linked to CHOP using real-world data.

methodsThis research collected and analyzed adverse event reports associated with CHOP from the FAERS(US Food and Drug Administration Adverse Event Reporting System) database spanning from the first quarter of 2004 to the third quarter of 2024. This study leveraged the FAERS database, extracting reports submitted exclusively by healthcare professionals where CHOP was designated as the primary suspect (PS). Four risk signal detection methods were employed: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multiitem Gamma Poisson Shrinker (MGPS), to conduct a comprehensive analysis of CHOP-related ADRs.

resultsA total of 3,625 adverse event reports with CHOP as the primary suspect drug were obtained. Across 25 system organ classes (SOCs), four positive Preferred Terms(PTs) signals were detected. The most significant signal in SOCs was "blood and lymphatic system disorders" (ROR = 6.64, 95% CI 6.49-6.79), while the most significant PTs signal was "high grade B-cell lymphoma Burkitt-like lymphoma recurrent" (ROR = 613.63, 95% CI 123.85-3040.40).

conclusionThis study provides compelling evidence of the presence of CHOP seven unexpected off-label AEs were also observed, such as mucoepidermoid carcinoma, hypotelorism of orbit, breakthrough COVID-19, airway remodeling, meningitis enteroviral, acute graft versus host disease, and gastrosplenic fistula. Additionally, the combination of CHOP and radiotherapy increased the risk of several severe AEs, such as hemorrhagic cystitis. These findings highlight the importance of caution when prescribing CHOP to high-risk individuals with a history of meningitis, cystitis or airway obstruction.

Indexed as

Adverse Drug Reaction Reporting SystemsCyclophosphamidePharmacovigilanceAdolescentAdultAgedBayes TheoremChildDatabases, FactualFemaleHumansMaleMiddle AgedPrednisoneUnited StatesUnited States Food and Drug AdministrationCyclophosphamidePrednisoneVincristine

Identifiers

PMID41494018
PMCPMC12774374

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.